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Abstract

VALIDATION OF STABILITY INDICATING HPLC METHOD FOR THE ASSAY OF FELODIPINE (API)

Saloni S. Wagh, Dr. Seema Kothari and Dr. Manohar V. Lokhande*

ABSTRACT

Three impurities were identified from Felodipine Active
Pharmaceutical Ingredient (API). The method for analysis for
felopdine is chosen high performance liquid chromatography (HPLC)
and was validated according to ICH guidelines. The Retention time of
standard solution is 12.952 mins and Retention time of sample solution
is 13.028 mins. System precision of its the RSD is 0.05% Method
precision the RSD is 0.30%. Overall RSD is 0.46% in Ruggedness.
The test method is validated for Specificity, Precision and Ruggedness
and found to be meeting the predetermined acceptance criteria. The
validated method is Specific, Precise and Rugged for Assay of
Felodipine API .Hence this method can be introduced into routine use for the assay of
Felodipine API. The parameters such as HPLC, Specificity, Precision, Ruggedness, System
Suitability and Linearity were analyzed.